Last Updated: July 5, 2026

Claims for Patent: 10,537,616

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Summary for Patent: 10,537,616

Title:	Method for improving the stability of purified factor VIII after reconstitution
Abstract:	The present disclosure relates to a method for increasing the stability of a Factor VIII molecule after purification, lyophilization and reconstitution, comprising preventing proteolytic cleavage of the Factor VIII molecule into a first fragment comprising essentially the A1 domain and the A2 domain and a second fragment comprising essentially the A3 domain, the C1 domain and the C2 domain throughout manufacturing the Factor VIII molecule. The disclosure further pertains to a method for improving the bioavailability of Factor VIII after intravenous and non-intravenous injection.
Inventor(s):	Carsten Horn, Sabine Zollner, Hubert Metzner, Stefan Schulte
Assignee:	CSL Ltd
Application Number:	US15/899,510

Details for Patent 10,537,616

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591	May 25, 2016	10,537,616	2038-02-20
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591	March 31, 2017	10,537,616	2038-02-20
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 10,537,616

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013057219	⤷ Start Trial
United States of America	9956269	⤷ Start Trial
United States of America	9394353	⤷ Start Trial
United States of America	2021308229	⤷ Start Trial
United States of America	2020268854	⤷ Start Trial
United States of America	2019038722	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

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